Critical examinations of studies and news on food, weight, health and healthcare, and our world -- information mainstream media misses. Debunks popular myths, explains science and exposes fraud that affects your health. Plus some fun food for thought. For readers not afraid to question and think critically to get to the truth.

February 27, 2008

Miracle thigh cream — new medical findings!

Our email inboxes are filled with spam promising miracle ways to lose fat and have thinner, more youthful figures. Most of us delete it unread or use spam filters to automatically throw it in the trash. Yesterday, medical professionals found in their inboxes a message for a fat-reducing cream, but a lot of people, seeing it came from a medical journal, probably read it. Some may have even believed it.

Editor-in-Chief of Medscape Journal of Medicine**, Dr. George D. Lundberg, M.D., described ‘exciting’ new findings that spot-reducing creams might actually work to make fat go away. He wrote in his Medical Minutes:

I'm Dr. George Lundberg. So many people struggle with body fat, generalized and localized. How wonderful it would be if a person could rub on a topical cream and make the fat go away. Three researchers at Louisiana State University recently published in the journal Diabetes, Obesity & Metabolism, a randomized, placebo-controlled clinical trial that asked this question. If 50 adult men and women with body mass indices over 27 kg/m were on a prescribed 1200-calorie balanced diet and a walking program, would the addition of the application of 0.5% aminophylline cream to the waist twice a day change BMI and waist circumference? After 12 weeks, the answer was yes, 11 cm less in the cream group and 5 cm less in the control group — a significant difference. BMI decreased in both groups; waist-to-hip ratios declined; women lost more; aminophylline blood levels were undetectable. Small sample size, but an exciting result, worthy of further study. [emphasis added]

Even when incredible claims, that sound too good to be true, come in the form of a study, our own spam detectors always need to be on. Are you curious what we weren’t told about this miracle fat-reducing cream or wondering: “How’d they do that?”

Figure flaws

This study was not a government registered clinical trial and does not appear on clinicaltrials.gov. The study was led by Mary K. Caruso, MS, a research assistant who reported it as part of her master’s thesis under co-author Dr. Frank Greenway, M.D., at the Pennington Biomedical Research Center in Baton Rouge, Louisiana. Pennington was established by Claude Bouchard, Ph.D., outgoing president of the International Association for the Study of Obesity. This study was published in the May, 2007 issue of the peer-reviewed journal Diabetes and Obesity Metabolism.

The flaws in this study are too numerous to count. Fifty “overweight” adults (21-65 years of age) were enrolled in this study. All were told to follow a 1,200-calorie a day diet and “encouraged to follow a walking program.” Twenty women and 5 men were randomly assigned to the treatment group and were given aminophylline 0.5% cream to rub (15 cc) onto their waists twice a day throughout the 12-week study.

Dr. Lundberg incorrectly reported this randomized study as being a placebo-controlled, clinical trial. It was neither placebo-controlled nor double-blind. Those getting the treatment were not blinded and knew they had the cream that was supposed to melt fat. The researchers knew it, too. The researchers saw the treatment group every 2 weeks, encouraged them to follow their diets, continue their walking program and to apply the cream twice daily; took their vital signs, inspected their waists and asked them about any side effects. Each month, the intervention group also had blood drawn to measure for theophylline levels.

There was no placebo cream given to the control group. There was no follow-up to encourage them to follow their diets and exercise. The control group knew they were merely the controls.

At the beginning and end of the study, BMIs, waist and hip circumferences were measured. The evaluators knew which participants had gotten the cream and which hadn’t, yet the study didn’t control for how the measurements were taken: with clothes/shoes, on exhalation or inhalation, sucking in their tummy or relaxing, the position of the subject (sitting, standing, slouched, etc.), after a 12-hour fast or meal, or how many measurements were taken. The study didn’t control for age of the participants; or if the subjects had been weight stable or been dieting prior to the study, to control for stable metabolisms. The study didn’t control for the type (aerobic, weight lifting, etc.) or amount of exercise done, or measure lean muscle mass. In fact, the researchers made no note of how anyone in the study actually followed their diets or how much and what type of exercise they’d actually done. Most importantly, given it was purportedly evaluating fat reduction, the study made no measurements of body fat composition.

BMIs in the treatment group went from an average of 28.2 to 26.1 during the study; compared to the control group that went from an average BMI of 28.5 to 26.2. The control group actually lost a bit more weight. Both waist and hip measurements reduced during the dramatic weight loss. The changes in the waist-to-hip ratios between the treatment and intervention groups at the end of the study, however, actually differed by only 0.04cm — an imperceptible and easily manipulated difference [see above paragraph].

And, finally, 12 weeks isn’t even close to the 5 years that the FTC determined in its 2003 crack down on fraudulent weight loss claims, “Deception in Weight-Loss Advertising,” is necessary before credible claims can be made about the merits of any weight loss intervention.

Caruso and colleagues concluded that this trial demonstrates it is possible to cause “cosmetic redistribution of body fat” and spot reduction of fat wherever their cream is applied. “Thus, one can extend the principle of local fat reduction with aminophylline cream to both genders and to a body area different from the thigh,” they wrote. The theory proposed for how a topical cream might work was essentially that, just as aminophylline gets the heart pumping when it’s inhaled by asthmatics, the cream drinks through the skin and jump-starts the metabolism to burn off underlying fat. They found, however, no systemic effects of their cream and aminophylline levels were undetectable in all of the blood tests they conducted during the study.

How does this study add to the body of evidence on reducing creams? There is no body of evidence supporting fat-reducing creams in the medical literature. The only study they cited for the effectiveness of aminophylline cream was a paper published in a 1995 issue of Obesity Research by co-author Dr. Greenway and Dr. George Bray, director of the Pennington Biomedical Research Center. That paper had briefly summarized a trial of 2% aminophylline thigh cream in 12 women which had concluded “topical fat reduction for women’s thighs can be achieved without diet or exercise.”

The rest of the story

There were no disclosure statements in this published paper, led by Caruso. In this case, such disclosures are noteworthy. Dr. Greenway first developed this aminophylline cream in the 1980s with Dr. Bray at Pennington. And Dr. Greenway holds the patents for anti-cellulite, fat spot reducing creams, applied for in 1985-1986.

They published their first thigh cream study in an obscure journal, Clinical Therapeutics, in 1987. Twenty-eight fat women had been placed on a strict low-calorie diet and 5 different creams or injections were tested. Five of the women had been given the aminophylline cream. The authors reported that thigh measurements were less after 4 weeks among all of the treatment groups. The study received little notice.

The Los Angeles Business Journalreported on April 4, 1994, that Drs. Greenway and Bray had been trying, unsuccessfully, for years to find potential financial backers in their spot-reducing cream. They sold licensing rights to Dr. Bruce Frome, a colleague at Harbor UCLA Medical Center, in 1992 who also tried to find backers. As reported by Robin Berger for the LA Business Journal, major drug companies “felt that it was too frivolous for them.” She went on to report:

Realizing that the product’s selling point was really cosmetic, the three physicians decided to shift gears — focusing on cellulite elimination instead of girth reduction. Greenway and Bray then began working on developing a product to smooth out dimpled thighs, which requires less aminophylline than their earlier girth-reduction product.

In early 1993, Frome licensed multilevel marketing distribution rights to the new creamy cosmetic to Orange-based D&F Industries. But the big breakthrough for the thigh cream and its proponents came last October at a conference sponsored by the North American Association for the Study of Obesity.

In October, 1993, at the NAASO meeting they presented their study [the one mentioned in the 1995 issue of Obesity Research above] of 12 women. They reported that only 8 women had completed the study and that the thigh cream resulted in as much as 1.5 cm lost around their thighs. This got media attention. Associated Press headlined with “Researchers describe cream that shrinks thighs” and USA Today reported news of the new “miracle thigh cream.” This publicity enabled them to find a retail distributor, Nutri/System weight loss center, to buy the license to sell their cream.

It would became best known as a cellulite cream and magical solution for “cottage-cheese” thighs. Remember when advertisements for these miracle creams seemed to be everywhere? The surge in popularity of thigh creams also caught the attention of the FDA, which began investigating the safety of these creams, FDA spokesman Mike Schaeffer told the LA Business Journal.

But no other researchers have been able to credibly replicate the findings of Dr. Greenway and Bray.

Dr. Leroy Young, M.D., of Washington University in St. Louis (and chairman of the nonsurgical procedures committee of the American Society of Aesthetic Plastic Surgery) conducted a study on fat-melting creams and found that 16 out of 17 women showed no improvements in their thighs after two months. As was reported by The Mercury News on March 22, 1995, “happiness, at least in the form of thin thighs, might not come in a jar [at $30 each].”

Dr. Judith S. Stern, S.M., Sc.D., professor in the departments of Nutrition and Internal Medicine, Division of Clinical Nutrition and Metabolism, at the University of California, Davis, said at the 2003 FTC workshop on fraudulent weight loss advertising that their researchers’ efforts to replicate the research were unsuccessful.

Doctors at the Department of Plastic Surgery, Bradford Royal Infirmary, West Yorkshire, England, conducted a randomized, placebo-controlled, double-blind clinical trial of aminophylline cellulite thigh cream and another popular cream, endermologie, in 69 women. The researchers assessed the results after 12 weeks by clinical examination, photographic assessment by the surgeon, body mass index, thigh girth at two points, and thigh fat depth measurement by ultrasound. No statistical difference existed in measurements between legs for any of the treatment groups. The researchers reported their results in a 1999 issue of Plastic and Reconstructive Surgery and concluded that these thigh creams are not effective and don’t improve the appearance of cellulite.

Pharmacology professors at the University of Kentucky, Lexington, reviewed the evidence for aminophylline thigh creams for cellulite and found the two reports by Dr. Greenway and Bray. The professors reported in the 1999 Annals of Pharmacotherapy that no studies to date have demonstrated safety and efficacy and these creams are “a dream cream.”

At the FTC 2003 workshops, held as part of its efforts to curb false and deceptive advertising of weight loss products, a scientific panel of researchers, academicians, medical professionals and industry experts examined the scientific evidence to date. They evaluated weight loss creams, nonprescription drugs, dietary supplements, wraps or patches and found claims that they can cause permanent weight loss to be “not scientifically feasible.” Claims that anything worn on the body or rubbed into the skin can help users lose weight — “Thigh Cream drops pounds and inches from your thighs” — would also constitute an unapproved drug in violation of the FDA, they said. The FTC stated that since 1990, it has challenged numerous products in this category, including acupressure devices, skin patches, slimming insoles, body wraps, and creams, charging that “efficacy claims for these products were not supported by reliable scientific evidence.”

The FTC also examined spot-reducing products. The weight loss experts noted that it is biologically impossible to lose fat preferentially from a single fat store, such as the thighs or buttocks. Their expert committee spent time specifically discussing research on aminophylline cream. They found that the only studies in the literature are extremely small and lasting only 4-6 weeks, with methodological shortcomings as well as inconsistent and “extremely small” effects. Based on the evidence and analyses to date, the FTC found weight loss creams were “not scientifically feasible at this time.”

The FDA has issued Warning Letters to companies selling anti-cellulite and weight reducing creams and making drug-like claims. In its January 22, 2004 letter to University Medical Products USA, Inc., in Irvine, California, the FDA objected to the claims that anti-cellulite thigh creams reduced thigh circumference, stimulated the release of stored fat or were clinically proven. It also found claims that weight reducing creams break down unwanted fat, stimulate metabolism and help lose inches and pounds. “Because these drugs are not generally recognized as safe and effective when used as labeled,” said the FDA, they cannot be legally marketed in this country.

Is it spam advertising or a study published in a medical journal? Sometimes, it’s both. :)

** Medscape, which delivers health information and free continuing education credits to doctors and nurses, is one of the online publications owned and operated by WebMD Health Network. WebMD reports it now reaches 44.8 million visitors each month. It supplies much of the online health information reaching consumers and found on employer and insurer health risk assessments, and preventive health and wellness programs. WebMD also has a Weight Loss Clinic and its obesity reference material is offered in collaboration with The Cleveland Clinic.

WebMD announced just last Thursday that its 2007 revenue was $332.0 million compared to $248.8 million a year ago, an increase of 33%.

We've seen another example that it is impossible to judge the reliability and soundness of information by the size, prestige or popularity of a website. Comparing actual study results with the information WebMD provides gives daily opportunities for critical thinking.